About the FDA draft guidance: responding to requests for off-label information

A lack of guidance from regulatory bodies is often blamed for pharma’s slow uptake of social media marketing tools. As a result, draft guidance issued by the FDA last month has generated considerable excitement – for the first time, digital channels have been addressed in a specific way and we are afforded some insight into what the FDA think about social media. Download the full FDA draft guidance (pdf), or look at Jonathan Richman’s blog with an easy-to-read flowchart, the FDA guidance translator (pdf). Although the recommendations are limited as to how firms should respond to unsolicited requests for off-label information about their products, including those received via electronic media, they are important because they:

• Acknowledge the importance of social media in healthcare communications and indicate a level of commitment by the FDA to help pharma use social media properly
• Provide a framework for how to deal with sensitive information in the digital space. E.g. Requests for off-label information made through public forums (websites, Facebook, YouTube etc.) should be dealt with by medical or scientific personnel, via a non-public, one-to-one communication
• Should give companies that have shied away from social media the confidence to take their first steps towards more meaningful engagement with their customers.

Pharma have a valuable role to play in disseminating accurate and up to date information about their products, and if conversations about those products are happening online and in public forums that is where they need to be. Pharma digital strategies should focus on developing social media tools that facilitate sensible, honest and, where necessary, discreet communication, building trust with regulators and customers. We have also written a summary of the FDA guidance for those of you who would like to quickly understand the important points. I co-authored this post with Sally Leon, our Senior Scientific Advisor.